PRIM-ER

January 21, 2022: Primary Palliative Care for Emergency Medicine (Corita R. Grudzen, MD, MSHS, FACEP)

Posted on by terren.green@duke.edu

Speaker

Corita R. Grudzen, MD, MSHS, FACEP
Professor, Emergency Medicine and Population Health
Associate Dean, Clinical Sciences
Deputy Director, Clinical and Translational Science Institute
Vice Chair for Research, Emergency Medicine
Ronald O. Perelman Department of Emergency Medicine
NYU Grossman School of Medicine

Keywords

Palliative Care; Stepped-Wedge study design; Emergency Department (ED); Gagne Index; PRIM-ER

 

Key Points

  • The Emergency Department is increasingly seeing older adults with serious illness rather than patients with acute trauma.
  • Primary Palliative Care for Emergency Medicine (PRIM-ER) is a stepped-wedge study partnership of 18 health systems in 33 EDs designed to change the culture and norms of emergency care to promote palliative care at home or hospice rather than admittance to the hospital.
  • The study used the Gagne Index greater than 6 to identify patients at high risk of short-term mortality. Patients with dementia did not need to meet the Gagne Index criteria to be included in the study.
  • A baseline survey, training of 2,470 emergency providers, and study intervention has been completed at all 33 sites.
  • Only .2% of ED patients in the study were admitted to hospice after their ED visit.  At 12 months post ED visit, 30% of dementia patients had died whereas 15.6% of the non-dementia chronic disease patients had died. Data analysis is ongoing.

Discussion Themes

Stepped-wedge studies present timing issues and COVID-19 increased these problems. A cluster randomized design may have been easier to implement.

 

The PRIM-ER study was considered quality improvement by the IRB, so no human subjects approval from the IRB was required.

 

The PRIM-ER next step will be developing tools for patients with dementia regarding palliative care in the ED.

 

Learn more about the PRIM-ER study.

 

Tags

#pctGR, @Collaboratory1

January 19, 2022: PCT Grand Rounds Will Feature PRIM-ER Study of Primary Palliative Care in Emergency Medicine

Posted on by Damon Seils
Headshot of Dr. Corita Grudzen
Dr. Corita Grudzen, principal investigator of PRIM-ER

In this Friday’s PCT Grand Rounds, the principal investigator of PRIM-ER, an NIH Collaboratory Trial, will share an update on the implementation of this innovative pragmatic clinical trial.

Principal investigator Dr. Corita Grudzen of the NYU Grossman School of Medicine will present “Primary Palliative Care for Emergency Medicine.” The Grand Rounds session will be held on Friday, January 21, at 1:00 pm eastern.

PRIM-ER, or the Primary Palliative Care for Emergency Medicine study, is a cluster randomized pragmatic trial of a multidisciplinary primary palliative care intervention that consists of education, clinical decision support, and other elements in a diverse mix of emergency departments in the United States. The intervention is intended to improve the delivery of goal-directed emergency care of older adults.

Join the online meeting.

PRIM-ER is supported within the NIH Collaboratory by a cooperative agreement from the National Institute on Aging.

December 15, 2020: A Year of Results and New Insights From the NIH Collaboratory

Posted on by Damon Seils

Collection of Journal CoversNIH Collaboratory researchers in 2020 reported study results, generated new knowledge, and developed innovative research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, analyses from the NIH Collaboratory Distributed Research Network, and results and methodological approaches from the NIH Collaboratory Trials.

So far this year, the NIH Collaboratory has produced more than 3 dozen articles in the peer-reviewed literature, including the primary results of the PROVEN and LIRE trials, the study design of ACP PEACE, insights into the COVID-19 pandemic from TSOS and EMBED, and more:

NIH Collaboratory Coordinating Center

NIH Collaboratory Distributed Research Network

ACP PEACE NIH Collaboratory Trial

EMBED NIH Collaboratory Trial

HiLo NIH Collaboratory Trial

LIRE NIH Collaboratory Trial

PPACT NIH Collaboratory Trial

PRIM-ER NIH Collaboratory Trial

PROVEN NIH Collaboratory Trial

SPOT NIH Collaboratory Trial

STOP CRC NIH Collaboratory Trial

TSOS NIH Collaboratory Trial

November 2, 2020: PRIM-ER Pilot Study Identifies Keys to Implementation Success

Posted on by Damon Seils

Cover image of JGIMIn a qualitative analysis of the PRIM-ER pilot study, receiving the support of institutional leadership and leveraging existing institutional processes emerged as keys to successfully implementing the study intervention.

The results of the analysis were published last week in the Journal of General Internal Medicine.

PRIM-ER, an NIH Collaboratory Trial, is a stepped-wedge cluster randomized clinical trial that will test a multidisciplinary primary palliative care intervention consisting of education, clinical decision support, and other elements in a diverse mix of emergency departments in the United States. The intervention is intended to improve the delivery of goal-directed emergency care of older adults.

In the pilot study, the research team launched the intervention in 2 emergency departments. The purpose of the qualitative analysis was to measure and evaluate the reach and effectiveness of the intervention. Both sites in the pilot study achieved a high level of reach, or intervention completeness. The intervention’s effectiveness—in terms the success of its implementation—was enhanced by support from institutional leadership and use of the sites’ existing processes for quality improvement. The findings will guide the research team as they implement the intervention at additional study sites.

PRIM-ER is supported within the NIH Collaboratory by a cooperative agreement from the National Institute on Aging. Read more about PRIM-ER.

June 1, 2020: New Chapter in the Living Textbook Shares Best Practices for Clinical Decision Support in Pragmatic Trials

Posted on by Karen Staman

A new chapter in the Living Textbook describes special considerations and best practices for designing and evaluating clinical decision support (CDS) for use in embedded pragmatic clinical trials (ePCTs). CDS functionality can support recruitment, enable the delivery of a new intervention, or be the intervention under evaluation.

The main topics of the chapter are:

The chapter also includes several case examples of CDS used to support the NIH Collaboratory Trials.

December 18, 2019: NIH Collaboratory Shares New Findings and Fresh Insights in 2019

Posted on by Damon Seils

NIH Collaboratory researchers in 2019 continued to generate new knowledge and research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, large-scale analyses of data from the NIH Collaboratory Distributed Research Network, and results and innovative methodological approaches from the NIH Collaboratory Trials.

So far this year, the NIH Collaboratory has produced nearly 3 dozen articles in the peer-reviewed literature, including the primary results of the ABATE Infection trial, confirmation by the TiME trial of the feasibility of embedding large pragmatic trials in clinical care, and more:

NIH Collaboratory Coordinating Center

NIH Collaboratory Distributed Research Network

ABATE Infection NIH Collaboratory Trial

EMBED NIH Collaboratory Trial

PPACT NIH Collaboratory Trial

PRIM-ER NIH Collaboratory Trial

PROVEN NIH Collaboratory Trial

SPOT NIH Collaboratory Trial

STOP CRC NIH Collaboratory Trial

TiME NIH Collaboratory Trial

TSOS NIH Collaboratory Trial

July 15, 2019: PRIM-ER Gains Approval to Proceed to Implementation Phase: An Interview With Dr. Corita Grudzen

Posted on by Damon Seils

Primary Palliative Care for Emergency Medicine (PRIM-ER)Dr Corita Grudzen, an NIH Collaboratory Trial, received approval this month to enter its implementation phase. PRIM-ER is a pragmatic, cluster randomized trial of a multidisciplinary primary palliative care education and decision support intervention in a diverse sample of emergency departments that differ in their specialty geriatric and palliative care capacity, geographic region, payer mix, and patient demographic characteristics.

We spoke with the principal investigator of PRIM-ER, Dr. Corita Grudzen, at the NIH Collaboratory Steering Committee meeting in May about the completion of the study’s planning phase.

What is the status of your study?

PRIM-ER is currently transitioning from a 1-year UG3 planning phase to the UH3 implementation phase, where the intervention will be tested at full scale across 33 sites in a stepped-wedge trial. Our program manager is conducting training sessions in preparation for implementing the intervention at study sites.

Were there surprises during the planning phase of the study?

There weren’t surprises so much as confirmation of what we already knew, which was that enthusiasm can go a long way. Having a detail-oriented, responsive site principal investigator is also key. When you have a well-organized team on the ground, the distance doesn’t matter as much, and all the things you think are going to get in the way don’t get in the way. Things go smoothly when you have someone who is incredibly enthusiastic, loves the content, understands the content, and is infectious about sharing the training and information with others. I think that can overcome a lot of potential barriers.

What is an example of a challenge that you were able to overcome with the help of the NIH Collaboratory Core Working Groups?

Working with the Cores was reassuring, in that they showed us we weren’t alone. We were all struggling with the same issues, and it was okay not to be perfect in the way we were attacking all the problems. We were all planning pragmatic trials, and it was okay if we showed our warts and all.

What other challenges have you faced?

Having a good team at the primary organization is really important. It’s important to have a good administrative team—a program manager, project director—who can hold down the fort, especially with pragmatic trials, when you’re traveling to a lot of sites.

What advice do you have for investigators conducting their first embedded pragmatic clinical trial?

Give yourself a break. There are a ton of imperfections in conducting embedded pragmatic trials. It’s all about the people. Pick great site principal investigators. That’s more important than anything else about the institutions. You want to have enough eligible patients that you’re going to have an impact or whatever else is involved in picking your sites. Enthusiasm and organizational savvy go a long way. Be patient and flexible and open to new iterations of what you’re doing. It feels scary at first, but I think it will serve you to be open to change.

PRIM-ER is supported within the NIH Collaboratory by cooperative agreements from NCCIH and the National Institute on Aging and receives logistical and technical support from the NIH Collaboratory Coordinating Center. Read more about PRIM-ER and the NIH Collaboratory Trials.

September 4, 2018: Spotlight on a New NIH Collaboratory Trial: PRIM-ER

Posted on by Damon Seils

In the United States, half of persons 65 years and older have an emergency department visit in the last month of life, and three-quarters have an emergency department visit in the last 6 months of life. Admissions to intensive care units by emergency clinicians are on the rise, especially for older patients. Meanwhile, three-quarters of older adults with serious illness have thought about end-of-life care, and only 12% want life-prolonging care.

The Primary Palliative Care for Emergency Medicine (PRIM-ER) pragmatic clinical trial will address this gap in the delivery of goal-directed emergency care of older adults. PRIM-ER will implement primary palliative care in a diverse group of 35 emergency departments. The trial will test the hypothesis that older patients with serious, life-limiting illness who receive care from clinicians with primary palliative care skills are less likely to be admitted to inpatient settings, are more likely to be discharged home or to palliative care service, and will have higher home health and hospice use, fewer inpatient days and intensive care unit admissions at 6 months, and longer survival than patients receiving care before implementation of the intervention.

“Giving emergency nurses, physician assistants, doctors the knowledge and skills they need to better care for patients with serious illness will ease symptom burden, improve quality of life, and get patients to the places where they want to be at the end of life.”

As a new addition to the NIH Collaboratory’s family of innovative NIH Collaboratory Trials, the PRIM-ER trial will feature evidence-based, multidisciplinary primary palliative care education; simulation-based workshops on communication in serious illness; clinical decision support, and provider audit and feedback.

PRIM-ER is led by principal investigator Dr. Corita Grudzen of New York University with support from the National Institute on Aging and the National Center for Complementary and Integrative Health. Watch a video interview with Dr. Grudzen, and read more about PRIM-ER.

May 2018 Steering Committee and Onboarding Meeting: Nudge, PRIM-ER, P4TH, EMBED, ACP PEACE, and HiLo

Steering Committee Meeting

May 14-16, 2018
Bethesda, MD

Main Purpose

Day 1: Welcome the new UG3 NIH Collaboratory Trials; provide introductions, an overview of the Collaboratory, and an understanding of the Core Working Groups; and discuss lessons learned, data sharing, and current ethics and regulatory issues.

Day 2: Celebrate the Collaboratory's progress; kick off the next 5 years; receive updates from the Core Working Groups; and hear about the top barriers/challenges and lessons learned from the UH3s.

Day 3: Intensive workshop to start discussions on embedded A vs. B pragmatic clinical trials.

Monday, May 14, 2018

Welcome, Opening Remarks, and Introductions
David Shurtleff, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Overview of a Cooperative Agreement
Wendy Weber, ND, PhD, MPH

Overview of the NIH HCS Research Collaboratory Program
David Shurtleff, PhD

Panel of Directors: Richard Hodes, MD; Wilson Compton, MD; David Murray, PhD; Bill Riley, PhD; Gary Gibbons, MD; Rob Star, MD

Collaboratory Coordinating Center Overview and Goals
Adrian Hernandez, MD, MHS

Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials
Jonathan McCall, MS

Policies and Guidance Documents

NIH Collaboratory Data Sharing Policy and Considerations
Adrian Hernandez, MD, MHS

Publications and Products Process
Eric Larson, MD, MPH

Data Quality
Rachel Richesson, PhD, MPH

New UG3 NIH Collaboratory Trials Updates
Brief overview of the projects

NIH and Other Requirements for ClinicalTrials.gov Reporting
Deborah Zarin, MD

Results Reporting of ePCTs
Adrian Hernandez, MD, MHS

Distributed Research Network Query Capabilities
Richard Platt, MD; Lesley Curtis, PhD

Closing Remarks
David Shurtleff, PhD; Richard Hodes, MD; Lesley Curtis, PhD 

Tuesday, May 15, 2018

Welcome and Opening Remarks
David Shurtleff, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Landscape of National ePCT Initiatives
Explanation of initiatives that are promoting ePCTs and future directions

Health Systems Engagement Issues and Lessons Learned from the Health Care Systems Interactions Core
Eric Larson, MD, MPH

UH3 NIH Collaboratory Trials
Top barriers/challenges and recent generalizable lessons learned

 

Tuesday, May 15, 2018 (Continued)

Discussion From New UG3 NIH Collaboratory Trials
Overview of project and discussion

CMS Quality Measures
Reena Duseja, MD

Lessons Learned From Core Groups
Discussion on generalizable knowledge created out of the Cores, how it can be used, and future work of the Cores

Data Sharing Principles and Lessons Learned
Greg Simon, MD, MPH

Closing Remarks
David Shurtleff, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Wednesday, May 16, 2018

Welcome and Introduction
David Shurtleff, PhD; Richard Hodes, MD; Catherine Meyers, MD; Wendy Weber, PhD, MPH

Panel Discussions

Panel 1: Partnering With Stakeholders to Conduct Embedded A vs. B Trials: Keys to Success Moderator: Rich Platt, MD, MSc

  • Steve Friedhoff, MD
  • Kenneth Sands, MD, MPH
  • Joseph Chin, MD

Panel 2: Examples in Action: Embedded A vs. B Trials Moderator: Beverly Green, MD, MPH

  • Ryan Ferguson, ScD, MPH
  • Susan Huang, MD, MPH
  • Michael Kappelman, MD, MPH

Panel 3: Maximizing the Pragmatic: Understanding Approaches to Design of Embedded A vs. B Trials Moderator: Greg Simon, MD, MPH

  • Scott Solomon, MD
  • Rachael Fleurence, PhD
  • Kourtney Davis, PhD, MSPH

Panel 4: Regulatory Aspects of Clinical Research and the Regulation of Products for Embedded A vs. B Pragmatic Trials Moderator: Adrian Hernandez 

  • Jacqueline Corrigan-Curay, MD, JD
  • Owen Faris, PhD
  • Julie Kaneshiro, MA

Panel 5: Ethical and IRB Approaches for a Successful Embedded A vs. B Pragmatic Trials Moderator: David Wendler, PhD

  • Barbara Bierer, MD
  • Spencer Hey, PhD
  • Judith Carrithers, JD, MPA

Summary Expert Panel Discussion Moderator: Cathy Meyers, MD

  • Adrian Hernandez, MD
  • Rich Platt, MD, MSc
  • Beverly Green, MD, MPH
  • Greg Simon, MD, MPH
  • Dave Wendler, PhD

Concluding Remarks 
Adrian Hernandez, MD, MHS; Rich Platt, MD, MSc